ASI’s System for FISH Analysis of Bladder Cancer Cells Receives FDA Clearance

Applied Spectral Imaging (ASI) announced yesterday that the ASI’s GenASIs Scan & Analysis, SpotScan, has been cleared by the United States Food and Drug Administration (FDA) for the detection of chromosomal aberrations in bladder cancer.

The GenASIs Scan & Analysis, SpotScan UroVysion targets cells of interest based on color, size and their signals pattern for use as a diagnostic aid for automated and manual classification of bladder cancer cells. The test can also assist in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. UroVysion is used for the detection of cells in urine specimens, stained with fluorescence in situ hybridization (FISH) using the Vysis UroVysion® Bladder Cancer Kit. The kit detects aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus.

ASI now offers 3 major FDA cleared computerized diagnostic aids: HER2/neu for breast cancer; CEP XY for assessing bone marrow transplantation effectiveness; and now the newly cleared UroVysion test for the detection of bladder cancer.

ASI’s manual and automated scanning platform and image analysis systems enable laboratories to provide highly reliable UroVysion test results quickly and cost-effectively.

Dr. Felipe Dominguez MD, President and CEO of Suncoast Pathology Associates said, “Using the GenASIs system from ASI is like having an efficient robotic assistant helping us perform fully automated UroVysion® Bladder Cancer scanning.” Dr. Dominguez further added that “The combined microscope and computer-aided image analysis capabilities of GenASIs help us give faster and more accurate clinical results. GenASIs takes automated UroVysion scanning and analysis to a new level.”

Limor Shiposh, ASI’s Chief Executive Officer said, “We are pleased to have received this important FDA clearance. We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost effectively. I am confident that this addition will help further establish ASI as the world leaders in automated and manual FISH imaging and analysis.”